Evaluation of a Novel Method for Integrating Insulin Delivery and Glucose Sensing in Adipose Tissue of Diabetic Patients

Type 1 Diabetes Clinical Trial

Official title:

A Single Center, Open-Labeled Exploratory Study to Evaluate a Novel Method for Integrating Insulin Delivery and Glucose Sensing in Subcutaneous Tissue of Type-1 Diabetic Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00813410
• Other study ID #: ZIG96
• Status: Completed
• Phase: N/A
• First received: December 20, 2008
• Last updated: December 20, 2008
• Start date: February 2007
• Est. completion date: December 2007

Study information

• Verified date: December 2008
• Source: Medical University of Graz
• Contact: n/a
• Is FDA regulated: No
• Health authority: Austria: Agency for Health and Food Safety
• Study type: Interventional

Clinical Trial Summary

The study seeks to use microdialysis and microperfusion techniques to assess the feasibility of performing insulin delivery and glucose sensing at a single subcutaneous tissue site.

Description:

Glucose management in type 1 diabetic patients comprises the measurement of glucose in capillary blood obtained by fingersticking and administration of exogenous insulin in the form of a subcutaneous bolus injection or continuous subcutaneous infusion.

The present study seeks to test an alternative treatment approach that combines glucose measurement and insulin delivery at a single subcutaneous tissue site, thereby circumventing the need for fingerstick blood glucose monitoring. Microperfusion and microdialysis probes are applied in type 1 diabetic subjects to perform insulin delivery and glucose sampling at the same adipose tissue site. The feasibility of estimating blood glucose concentrations from the glucose levels measured at the subcutaneous insulin delivery site is then assessed during an overnight fast and an oral glucose tolerance test.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 14
• Est. completion date: December 2007
• Est. primary completion date: December 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• Type 1 diabetes mellitus patients aged 18 - 65

• C-peptide negative (= 0.05 nmol/L)

• HbA1c (glycosylated haemoglobin A1c) < 10%

• Body Mass Index: 21 - 30 kg/m2

• Informed consent obtained before any trial-related activities.

Exclusion Criteria:

• Severe diabetic complications (e.g., proliferative retinopathy, severe nephropathy)

• Female of childbearing potential who is pregnant, breast-feeding or intends to become pregnant or is not using adequate contraceptive methods

• Any condition that would interfere with trial participation or evaluation of results, as judged by the investigator

• Treatment with drugs that could interfere with glucose metabolism and subcutaneous insulin absorption

• Subject with mental incapacity or language barriers

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Type 1 Diabetes

Intervention

Procedure:
• Glucose measurement at the sc. insulin delivery site
Overnight fasting and oral glucose tolerance test (OGTT) combined with simultaneous subcutaneous insulin delivery and glucose sampling using a single microdialysis or microperfusion probe.

Locations

Country	Name	City	State
Austria	Medical University of Graz	Graz	Styria

Sponsors (1)

Lead Sponsor	Collaborator
Medical University of Graz

Country where clinical trial is conducted

Austria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	glucose concentration at the subcutaneous insulin delivery site		20 hours	No